01 1Alcaftadine
02 1Bexarotene
03 1Bortezomib
04 2Bromfenac Sodium
05 1Busulfan
06 2Cevimeline Hydrochloride
07 2Clofarabine
08 1Cyclophosphamide
09 3Dacarbazine
10 2Degarelix Acetate
11 2Dimetindene
12 1Enasidenib
13 1Felbamate
14 1Ferric Carboxymaltose
15 1Ferumoxytol
16 2Flibanserin
17 1Ganirelix
18 1Lurbinectedin
19 1Methyltyrosine
20 2Miglustat
21 2Nadolol
22 1Pantoprazole Sodium
23 1Penicillamine
24 1Perphenazine
25 2Phentolamine Mesylate
26 1Plerixafor
27 2Ponatinib
28 1Protriptyline
29 1Safinamide Mesylate
30 1Selegiline Hydrochloride
31 1Selexipag
32 1Semaglutide
33 2Sugammadex Sodium
34 2Sulfiram
35 1Tirzepatide
36 2Trabectedin
37 1Voriconazole
38 3Blank
01 25Active
02 3Inactive
03 27Blank
01 3Valid
02 52Blank
01 1231MF10057
02 54Blank
01 13WC-0110
02 1WC-0110A3
03 1WC-0110A4
04 1WC-0110A5
05 1WC-0110A6
06 9WC-0110a
07 29Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-22
Pay. Date : 2013-09-20
DMF Number : 22922
Submission : 2009-06-30
Status : Active
Type : II
Registration Number : 231MF10057
Registrant's Address : 49 Napoleon Ct. , Somerset, NJ 08873, USA
Initial Date of Registration : 2019-02-25
Latest Date of Registration :
NDC Package Code : 14096-140
Start Marketing Date : 2009-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-10
Pay. Date : 2015-05-27
DMF Number : 23924
Submission : 2010-08-05
Status : Active
Type : II
Certificate Number : R1-CEP 2016-270 - Rev 00
Issue Date : 2023-05-17
Type : Chemical
Substance Number : 542
Status : Valid
NDC Package Code : 14096-147
Start Marketing Date : 2011-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39948
Submission : 2024-06-07
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110
Address of the Firm :
NDC Package Code : 42973-194
Start Marketing Date : 2012-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-13
Pay. Date : 2021-06-07
DMF Number : 35828
Submission : 2021-04-19
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110
Address of the Firm :
NDC Package Code : 42973-310
Start Marketing Date : 2020-12-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35114
Submission : 2020-09-04
Status : Active
Type : II
Certificate Number : CEP 2022-362 - Rev 00
Issue Date : 2024-08-02
Type : Chemical
Substance Number : 2576
Status : Valid
NDC Package Code : 73223-005
Start Marketing Date : 2019-08-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32382
Submission : 2018-01-07
Status : Active
Type : II
NDC Package Code : 42973-204
Start Marketing Date : 2017-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-08-07
Pay. Date : 2015-07-29
DMF Number : 23631
Submission : 2010-04-26
Status : Active
Type : II
NDC Package Code : 14096-150
Start Marketing Date : 2009-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110
Address of the Firm :
NDC Package Code : 42973-144
Start Marketing Date : 2008-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110
Address of the Firm :
NDC Package Code : 42973-228
Start Marketing Date : 2017-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110
Address of the Firm :
NDC Package Code : 42973-173
Start Marketing Date : 2011-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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